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Welcome to our News Letter
Hello,
We are thrilled to present the latest edition of Patient Guard newsletter, your go-to source for the most current updates for medical device and in vitro diagnostic (IVD) regulations and standards.
Thank you for your continued trust and partnership. We hope you find this edition of our newsletter both informative and valuable. As always, we welcome your feedback and are here to support you in any way we can.
Kind regards,
The Patient Guard Team
Regulatory News - From January 2025
EU
UK
USA
- Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations – Draft Guidance for Industry and Food and Drug Administration Staff
- Pulse Oximeters (Updated)
- Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency – Draft Guidance for Industry and Food and Drug Administration Staff
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations – Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Device Supply Chain and Shortages (Updated)
New & Updated Medical Device Standards
